The National Institute for Clinical Excellence ( NICE ) has issued guidance to the NHS in England and Wales on the use of bisphosphonates ( Alendronate, Etidronate, Risedronate ), Raloxifene and Teriparatide for the prevention of further osteoporotic fragility fractures in postmenopausal women who have already had a fragility fracture.

It is estimated that 1.2 million women in the UK have osteoporosis.
Osteoporosis occurs when there is a loss of some of the materials that make up bones.
As a result the bones become fragile and can fracture easily.
The bones most likely to break are the hips, wrists and spine. Age is one of the major risk factors for primary osteoporosis.
It can affect both sexes, but women who have gone through the menopause are at particular risk because their ovaries no longer produce oestrogen, which helps to protect against bone loss.

NICE recommends the following:

Bisphosphonates ( Alendronate, Etidronate and Risedronate ) are recommended as treatment options for the secondary prevention of osteoporotic fragility fractures:

• in women aged 75 years and older, without the need for prior dual energy X-ray absorptiometry (DEXA) scanning;

• in women aged between 65 and 74 years if the presence of osteoporosis is confirmed by DEXA scanning, and

• in postmenopausal women younger than 65 years of age, if they have a very low bone mineral density ( BMD, that is with a T-score 1 of approximately –3 SD or below, established by a DEXA scan ), or if they have confirmed osteoporosis plus one, or more, additional age-independent risk factor:

- low body mass index (< 19 kg/m2 )

- family history of maternal hip fracture before the age of 75 years

- untreated premature menopause

- certain medical disorders independently associated with bone loss ( such as chronic inflammatory bowel disease, rheumatoid arthritis, hyperthyroidism or coeliac disease )

- conditions associated with prolonged immobility.
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In their choice of bisphosphonate, clinicians and patients need to balance the drug’s overall proven effectiveness profile against tolerability and adverse effects in individual patients.

Raloxifene is recommended as an alternative treatment option to bisphosphonates as specified above in women:

• for whom bisphosphonates are contraindicated, or

• who are physically unable to comply with the special recommendations for use of bisphosphonates, or

• who have had an unsatisfactory response to bisphosphonates

• who are intolerant of bisphosphonates.

Teriparatide is recommended as a treatment option for the secondary prevention of osteoporotic fragility fractures in women aged 65 years and older who have had an unsatisfactory response to bisphosphonates or intolerance to bisphosphonates, and:

• who have an extremely low BMD ( with a T-score of approximately –4 SD or below ), or

• who have a very low BMD ( with a T-score of approximately –3 SD or below ) plus multiple fractures ( more than two ) plus one, or more, additional age-independent risk factor: low body mass index ( < 19 kg/m2 ); family history of maternal hip fracture before the age of 75 years; untreated premature menopause; conditions associated with prolonged immobility.

Source: NICE, 2005


XagenaMedicine2005